In den westlichen Industrienationen gilt das Prinzip der informierten Einwilligung als das Zentralelement medizinischer Forschungsethik. In anderen, stärker die Relationalität als die Individualität von Personen betonenden Kulturen hingegen werden medizinische Entscheidungen traditionell eher durch die Gemeinschaft bzw. ihr Oberhaupt getroffen. Um verschiedenen kulturellen Normen gerecht zu werden, wird international tätigen Forschungsteams häufig empfohlen, den Community Consent und den Informed Consent einzuholen. Ausschlaggebend soll dabei letztlich der Informed Consent des Individuums sein. Es soll die Teilnahme auch dann verweigern können, wenn die (...) Gemeinschaft bzw. ihr Repräsentant dem Vorhaben zugestimmt hat. Der Beitrag diskutiert, ob eine solche Kopplung von Community Consent und Informed Consent tatsächlich geeignet ist, den Ansprüchen beider Prinzipien gerecht zu werden. Es wird argumentiert, dass die Kopplung von Community Consent und Informed Consent ethisch problematisch ist, wenn der Gemeinschaft hierbei ein Vetorecht eingeräumt wird, das geeignet ist, die Realisation konträrer individueller Interessen und damit das Selbstbestimmungsrecht der Betroffenen zu unterlaufen. Um zu gewährleisten, dass in interkulturellen Forschungszusammenhängen sowohl der individuellen als auch der relationalen Autonomie von Personen angemessener Raum gewährt wird, wäre es empfehlenswert, den Informed Consent ausdrücklich mit einer Community Consultation zu koppeln. Hier käme die Entscheidung gegen, aber auch für eine Studienteilnahme in letzter Instanz klar dem Individuum zu, während die Vorzüge einer Einbeziehung der Gemeinschaft in den Entscheidungsfindungsprozess anerkannt und genutzt werden könnten. (shrink)

The principle of respect for human dignity plays a crucial role in the emerging global norms relating to bioethics, in particular in the UNESCO Universal Declaration on Bioethics and Human Rights. This instrument, which is a legal, not merely an ethical document, can be regarded as an extension of international human rights law into the field of biomedicine. Although the Declaration does not explicitly define human dignity, it would be a mistake to see the emphasis put on this notion as (...) a mere rhetorical strategy. Rather, the appeal to dignity reflects a real concern about the need to promote respect both for the intrinsic worth of human beings and for the integrity of the human species. But dignity alone cannot solve most of the dilemmas posed by biomedical practice. This is why international biolaw combines, on the one hand, the appeal to human dignity as an overarching principle with, on the other hand, the recourse to human rights, which provide an effective and practical way forward for dealing with bioethical issues at a global level. (shrink)

This paper targets an orphan topic in research ethics, namely the so called principle of the primacy of the human being, which states that the interests of the human subject should always take precedence over the interests of science and society. Although the principle occupies the central position in the majority of international ethical and legal standards for biomedical research, it has been commented in the literature mainly in passing. With a few notable exceptions, there is little in-depth discussion about (...) the meaning and role of the principle. Several authors note that the principle is vogue, ambiguous and apparently conflicting with the accepted practice of conducting non-beneficial research on individuals unable to give consent. There are opinions that it is just “a vacuous figure of speech” and should be abandoned. This paper argues that the primacy principle is far from being “a vacuous figure of speech”, rather it should be seen as a threefold concept: a fundamental interpretative rule, a procedural rule, and a substantive rule aimed at protecting research subjects from instrumental treatment and unacceptable risks. This interpretation tracks back to the principle regulatory and normative origins in the Declaration of Helsinki of 1975, but also acknowledges changes in research ethics and practice, which took place at the turn on the twentieth and twenty-first centuries. Thus, the proposed reading of the principle is not only original, but also historically grounded and normatively fruitful. It provides a fresh and ethically rich perspective on extensively debated, but still controversial problem of an upper limit of permissible risks in non-beneficial studies. (shrink)

Rigorous attention has been paid to moral distress among healthcare professionals, largely in high-income settings. More obscure is the presence and impact of moral distress in contexts of chronic poverty and structural violence. Intercultural ethics research and dialogue can help reveal how the long-term presence of morally distressing conditions might influence the moral experience and agency of healthcare providers. This article discusses mixed-methods research at one nongovernmental social support agency and clinic in Rio de Janeiro, Brazil. Chronic levels of moral (...) distress and perceptions of moral harm among clinicians in this setting were both violent, following Nancy Scheper-Hughes’ use of that term, and a source of exceptional and innovative care. Rather than glossing over the moral variables of work in such desperate extremes, ethnography in these settings reveals novel skills and strategies for managing moral distress. (shrink)

Humanitarian emergencies and natural disasters can overwhelm the capacity of local and national agencies to respond to the needs of affected populations. In such cases, international relief organizations are frequently involved in the provision of emergency assistance. Health care professionals play a key role in these interventions. This practice environment is significantly different from the context of health care delivery in the home countries of expatriate health care professionals. Clinicians who travel from a developed nation to a resource-poor setting where (...) a humanitarian crisis has occurred experience a shift of professional, social, cultural and regulatory environments. In this dissertation I examine the ethics of health care practice in humanitarian work. I evaluate the literature of global bioethics, global health ethics and the ethics of humanitarian assistance, and consider the contributions of various ethics frameworks and normative approaches. I also develop a set of questions to guide health care professionals as they address ethically complex issues arising in clinical practice during humanitarian crises. In the empirical component of this research program I use Interpretive Description methodology to examine the moral experience of health care professionals in humanitarian relief work, and clinician experiences of resources and constraints for addressing ethical issues in humanitarian settings. Building upon the inductively derived findings, I argue for strategies and approaches that humanitarian organizations, project teams, and health care professionals can adopt to respond to the ethics of this field of practice. I also provide a critical review of Interpretive Description methodology. The research presented in this dissertation makes an important contribution to the ethical analysis of health care practice in humanitarian work. (shrink)